Diagnosis, Treatment and Follow-up in Extracranial Carotid Stenosis
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MEDICINE Clinical Practice Guideline Diagnosis, Treatment and Follow-up in Extracranial Carotid Stenosis Hans-Henning Eckstein, Andreas Kühnl, Joachim Berkefeld, Holger Lawall, Martin Storck, Dirk Sander Summary Background: Around 15% of cerebral ischemias are caused by lesions of the extracranial carotid artery. The goal of this guide- line is to provide evidence- and consensus-based recommendations for the management of patients with extracranial carotid stenoses throughout Germany and Austria. Methods: A systematic literature search (1990–2019) and methodical assessment of existing guidelines and systematic reviews; consensus-based answers to 37 key questions with evidence-based recommendations. Results: The prevalence of extracranial carotid artery stenoses is around 4% overall, higher from the age of 65 years. The most important examination modality is duplex sonography. Randomized trials have shown that carotid endarterectomy (CEA) signifi- cantly reduces the 5-year risk of stroke in patients with 60–99 % asymptomatic stenoses (absolute risk reduction [ARR] 4.1% over 5 years, number needed to treat [NNT] 24) or 50–99% symptomatic stenoses (50–69%: ARR 4.6 % over 5 years, NNT 22; 70–99%: 15.9 % over 5 years, NNT 6). With the aid of intensive conservative treatment, the carotid artery-associated risk of stroke can be reduced to as little as 1% per year. Critical determination of indications and strict quality criteria are therefore necessary for CEA and carotid artery stenting (CAS). Systematic reviews of controlled trials comparing CEA and CAS show that the procedural risk of stroke is higher for CAS (asymptomatic: 2.6% versus 1.3%; symptomatic: 6.2% versus 3.8%). There are no differences in the long term. CEA is recommended as standard procedure for high-grade asymptomatic and moderate to high-grade symptomatic carotid artery stenoses; CAS may be considered as an alternative. For both procedures, the periprocedural combined rate of stroke or death should not exceed 2% for asymptomatic stenoses or 4% for symptomatic stenoses. Conclusion: Future studies should evaluate even better selection criteria for optimal individualized treatment, whether conservative, surgical, or endovascular. Cite this as: Eckstein HH, Kühnl A, Berkefeld J, Lawall H, Storck M, Sander D: Clinical practice guideline: Diagnosis, treatment and follow-up in extracranial carotid stenosis. Dtsch Arztebl Int 2020; 117: 801–7. DOI: 10.3238/arztebl.2020.0801 I Spokesman (HHE) and Secretary (AK) of the Steering Group, Department n around 15% of cases, cerebral ischemia is caused by forf Vascular and Endovascular Surgery, University Hospital “rechts der Isar”, Technical University of Munich: Prof. Dr. med. Hans Henning Eck- lesions of the extracranial segment of the carotid stein, Prof. Dr. med. Andreas Kühnl artery; for this reason, optimal treatment of carotid Member of the Steering Group, Institute for Neuroradiology, University stenoses is crucial (1). The interdisciplinary guideline Hospital Frankfurt: Prof. Dr. med. Joachim Berkefeld presented here evaluates and compiles the findings of the Member of the Steering Group, Ettlingen: Dr. med. Holger Lawall existing comparative studies on conservative and invasive Member of the Steering Group, Department of Vascular and Thoracic Sur- options for treatment of extracranial carotid artery gery, Karlsruhe Municipal Hospital: Prof. Dr. med. Martin Storck stenoses. The goal of this new guideline is to ensure Member of the Steering Group, Department of Neurology and Stroke Unit, evidence-based care of patients with extracranial carotid Benedictus Hospital Tutzing: Prof. Dr. med. Dirk Sander stenoses throughout Germany and Austria. German Vascular Society (DGG): Prof. Dr. med. Hans-Henning Eckstein The first multidisciplinary, evidence- and German Society of Neuroradiology (DGNR): Prof. Dr. med. Joachim consensus-based, joint German/Austrian guideline for Berkefeld the management of extracranial carotid stenoses was German Society for Angiology/Vascular Medicine (DGA): Dr. med. Holger published in 2012 (2). The present article summarizes Lawall the central recommendations of the updated clinical German Society of Surgery (DGCH): Prof. Dr. med. Martin Storck practice guideline, the long and short versions of German Society of Neurology (DGN): Prof. Dr. med. Dirk Sander which were published on the website of the Deutsches Ärzteblatt International | Dtsch Arztebl Int 2020; 117: 801–7 801
MEDICINE TABLE 1 eTable 2), systematic reviews, and meta-analyses (both from 2011 onward). Other types of studies, e.g., Important recommendations for asymptomatic carotid stenosis randomized controlled trials (RCT), cohort studies, New recommendations added to revised guideline Strength*1 LoE*2 and case–control studies, were also included if they contained data relevant to decision making or if All patients with asymptomatic carotid stenosis should be recommended to eat a balanced mixed whole-food diet and ↑↑ 2a neither guidelines nor systematic reviews with high- physical activity. Smoking must be ceased..*3 quality methods were available to answer one of the All patients with a ≥ 50% asymptomatic atherosclerotic carotid key questions. stenosis should take 100 mg aspirin/day, providing that the risk ↑ 2a The systematic literature search was carried out in of bleeding is low. the databases Medline, Embase, and the Cochrane In patients with diabetes mellitus and/or arterial hypertension, Database of Systematic Reviews; The search for the diabetes and/or hypertension should be treated according EC national and international guidelines was conducted to current guidelines.*3 in the database of the Guidelines International Net- All patients with a ≥ 50% asymptomatic atherosclerotic carotid work. The total number of primary records was 5566, stenosis should take a statin for long-term prevention of cardiovascular events (stroke, myocardial infarction, etc.). EC including 18 guidelines and 75 systematic reviews LDL cholesterol should be lowered, in a risk-adapted manner and meta-analyses. according to the current guidelines.*3 The records identified were assessed partly by In the presence of a 60–99% asymptomatic carotid stenosis, members of the steering group, partly by an external CEA should be considered, provided there is no increased organization (KSR; Kleijnen Systematic Reviews surgical risk and one or more clinical or imaging findings are ↑ 1 Ltd., York, UK) (eFigure).The key questions were available that are associated with an increased risk of carotid-related in follow-up each answered on the basis of the best evidence available from the publications, in the following In the presence of a 60–99% asymptomatic carotid stenosis, CAS may be considered, provided there is no increased descending order: guidelines, systematic reviews, treatment-associated risk and one or more clinical or imaging ↔ 2a meta-analyses, single RCT, other studies (cohort findings are available that are presumably associated with an studies, case–control studies). increased risk of carotid-related stroke in follow-up The structured consensus finding followed the rules of the AWMF. Recommendations were classified The periprocedural stroke/death rate should be as low as possible for CEA or CAS of an asymptomatic stenosis. The by means of arrows and using the system conventional ↑↑ 2a in-hospital stroke/death rate should be monitored by expert in German guidelines (eTable 3): neurologists and should not exceed 2%. ● ↑↑ corresponds to “strongly recommended”. ● ↑ corresponds to “ recommended” or “should be *1 Recommendation strength: ↑↑/↓↓, strongly recommended/definitely not recommended; ↑/↓, recommended/not recommended ↔, open recommendation considered”. *2 Level of evidence (LoE) 1–5 according to the Oxford Centre for Evidence-Based Medicine 2009 ● ↔ corresponds to “open recommendation” or (see guideline report for this clinical practice guideline) “may be considered”. *3 Equally valid for patients with asymptomatic and symptomatic carotid stenosis CAS, Carotid stenting; CEA, carotid endarterectomy; EC, expert consensus ● EC corresponds to “expert consensus” Recommendations against the use of a given inter- vention are classified into two categories: “definitely not recommended” and “not recommended”. The level Association of the Scientific Medical Societies in of evidence was determined in most cases by the evi- Germany (AWMF) in March 2020 (3). dence quality and was decided according to the stipu- lations of the Oxford Centre for Evidence-Based Methods Medicine 2009. If insufficient information was avail- Involvement of stakeholders and principles able, expert consensus (EC) recommendations were Twenty-one medical societies and organizations were reached by interdisciplinary discussion. involved in the revision of the guideline (eTable 1). In a process documented in the guideline report, all Results members of the guideline group provided written no- Epidemiology tification of any potential conflicts of interest. The The population-level prevalence of ≥ 50% carotid guideline is multidisciplinary and based on evidence stenosis, mostly caused by atherosclerosis, is around and consensus (an S3 classification in the German 4%. Carotid stenosis is associated with current grading of guidelines). Each society/organization was smoking, increasing age, male sex, and the presence entitled to cast one vote on every decision. All recom- of vascular disease (4). Around 15% of cases of cer- mendations were agreed at a consensus conference or ebral ischemia are caused by lesions of the extra- by means of a structured DELPHI process. cranial segment of the carotid artery (1). Owing to the optimization of conservative treatment, the risk Literature review and assessment of recommendations/ of a carotid-related ipsilateral cerebral infarction in a evidence patient with a > 50% asymptomatic stenosis is The systematic literature search carried out for the around 1% per year (5). If carotid-associated symp- purpose of updating the original guideline was re- toms occur, however, the risk of stroke rises to stricted to guidelines (published from 2014 onward, 11–25% within the first 14 days (6). 802 Deutsches Ärzteblatt International | Dtsch Arztebl Int 2020; 117: 801–7
MEDICINE Symptoms and diagnosis TABLE 2 The typical symptoms of extracranial carotid artery stenosis are retinal ischemia (e.g., amaurosis fugax), Important recommendations for treatment technique with CEA and CAS unilateral paresis or dysesthesia, and speech disorders CEA Strength*1 LoE*2 (aphasia) within the preceding 6 months. Dizziness as Modified: The selection of the surgical technique (eversion well as vertigo and memory disorders are atypical. A CEA, conventional CEA with patchplasty) should depend on ↑↑ 1a stenosis can also be classified as symptomatic if cer- the operating surgeon’s personal experience. ebral imaging demonstrates clinically silent ischemia Unchanged: Since there is no distinct difference between (eTable 4). the 30-day results after local/regional anesthesia or general The principal instrument-based examination is color- anesthesia, either can be used. In choosing between the ↑↑ 1 two, the patient’s preference and the individual experience coded duplex sonography (DUS) (↑↑) together with deter- and competency of the anesthesiological/vascular surgery mination of the extent of distal stenosis using the North team should be taken into account. American Symptomatic Carotid Endarterectomy Trial New: The anesthesiological/vascular surgery team should (NASCET) method (EC) (7). If there is any doubt about offer the option of local/regional anesthesia, because clamp- ↑ 2c grading, contrast-enhanced magnetic resonance angi- ing ischemia can be detected earlier in awake patients . ography (MRA) and computed tomography angiography CAS Strength*1 LoE*2 (CTA) can be carried out (EC). Symptomatic patients Unchanged: CAS should be preceded by dual platelet in- should undergo cerebral parenchyma imaging prior to caro- ↑ 3 hibition with aspirin (100 mg) and clopidogrel (75 mg). tid endarterectomy (CEA) or carotid artery stenting (CAS), New: Treatment with clopidogrel should be initiated at least and additional information may also be gained by this 3 days before the intervention at 75 mg/day or on the day EC means in asymptomatic patients (EC). Vascular risk factors before the intervention at 300 mg/day. and conditions resulting from atherosclerosis (coronary Unchanged: The dual platelet inhibition should continue for EC heart disease [CHD], peripheral arterial occlusive disease) at least 1 month. should be documented in all patients (EC). Routine screening for carotid stenosis is definitely *1 Recommendation strength: ↑↑/↓↓, strongly recommended/definitely not recommended; ↑/↓, recommended/not recommended ↔, open recommendation not recommended (↓↓). In the presence of vascular risk *2 Level of evidence (LoE) 1–5 according to the Oxford Centre for Evidence-Based Medicine 2009 factors, however, screening may be useful in cases (see guideline report for this clinical practice guideline) CAS, carotid stenting; CEA, carotid endarterectomy; EC, expert consensus where the diagnosis of extracranial carotid stenosis would have therapeutic consequences (EC). Patients with known carotid stenosis should be followed up at 6- to 12-month intervals (EC). Indications for revascularization of asymptomatic Treatment carotid stenoses Conservative treatment of asymptomatic RCT carried out in the 1990s showed that CEA in and symptomatic carotid stenosis > 60% asymptomatic carotid artery stenoses had a pre- The management of patients with atherosclerotic carotid ventive effect against stroke (12, 13). Owing to the stenosis should comprise both consistent risk factor modi- major improvements in the pharmaceutical prevention fication, including alterations of lifestyle (quitting smok- of atherosclerosis since then, the consensus conference ing, healthy, balanced wholefood nutrition, exercise; ↑↑), now recommends prophylactic CEA of 60 to 99% ste- and, if arterial hypertension and/or diabetes mellitus are noses only in patients in whom the surgical risk is not present, treatment according to the guidelines (EC) (Table elevated (Table 2, eTable 4). Moreover, there should be 1). The recommended medication is 100 mg aspirin daily one or more clinical or imaging findings that are associ- in asymptomatic stenoses (↑) and 100 mg aspirin or 75 mg ated with an elevated risk of carotid artery-related clopidogrel in symptomatic stenoses (↑↑). Statins should stroke during follow-up (NEW, ↑). For instance, men be taken for long-term cardiovascular prevention (EC). As have a much greater risk of stroke in the longer term advised in current guidelines, LDL cholesterol should be than women, who do not benefit from revascularization lowered to < 70 mg%, or to < 50 mg% in high-risk athe- measures until 10 years after treatment. Further impor- rosclerosis patients (8). tant findings are contralateral transient ischemic attack or stroke, silent infarction on cerebral imaging, marked Invasive treatment: carotid endarterectomy or carotid progression in extent of stenosis, predominantly echo- stenting lucent plaques on sonography, intraplaque hemorrhage Whether invasive treatment is indicated for a carotid ar- on MRI, a large plaque area (>80 mm2), spontaneous tery stenosis should be decided by an interdisciplinary microembolisms on transcranial Doppler sonography team including experienced neurologists (EC). The (TCD), and limited cerebrovascular reserve capacity procedural complication rate should be monitored (Table 3). In this situation, CAS may be considered neurologically (EC). There was strong consensus for all (NEW, ↔). The pharmaceutical treatment accompany- recommendations after detailed assessment of the lit- ing CEA comprises administration of aspirin (↑↑) and erature (8–11). Important recommendations regarding of statins (NEW, ↑↑). treatment technique and follow-up examinations can be In a systematic review (five RCT) (14) comparing found in Table 2 and eTable 5. CAS and CEA in asymptomatic stenoses, the Deutsches Ärzteblatt International | Dtsch Arztebl Int 2020; 117: 801–7 803
MEDICINE TABLE 3 Indications for revascularization of symptomatic carotid stenoses The influence of clinical and morphological variables on the risk of stroke in A Cochrane Review published in 2017 (16) evaluated the presence of an asymptomatic 60–99% carotid stenosis (modified from 8, 9) the individual patient data of three large RCT com- Clinical variables ARR/RR [95% CI], p-value paring CEA with BMT alone. CEA had no significant effect on the 5-year risk of ipsilateral stroke in 30–49% Men < 75 years (12) ARR in 5 years: 6.5% [3.6; 9.4] stenoses, but was advantageous in 50–69% stenoses Contralateral TIA/stroke (29) RR 3.0 [1.9; 4.73] (RR 0.84 [0.60; 1.18]) and significantly superior in Morphological variables OR/HR/ARR/RR [95% CI], p-value 70–99% stenoses (RR 0.47 [0.25; 0.88]) (Table 4). Silent infarction on CCT (30) HR 3.0 [1.46; 6.29] In a systematic review comparing CEA and CAS in symptomatic stenoses (nine RCT, 6984 patients) Extent of stenosis 50–69% vs. 70–99%, 1.6% vs. 2.4%/year (absolute risk) (17), the 30-day risk of stroke was 6.2% after CAS meta-analysis (5) against 3.8% after CEA (RR 1.62 [1.31; 2.00]). The Progression of 50–99% carotid stenosis RR 1.92 [1.14; 3.25] difference was still present at 48 months (RR 1.37 by at least 10% (29) [1.11; 1.70]). There was no significant difference Progression of 50–99% Progression by 1 category*, IRR 1.65 between the two procedures for the endpoints death carotid stenosis /year* (31) (1.1–2.45) and severe stroke. The 30-day risk of myocardial in- Progression by 2 categories*, IRR 4.73 (2.23–9.63) farction was 1% after CAS and 2.2% after CEA (RR 0.44 [0.26; 0.75]), while cerebral nerve lesions Echolucent plaques vs. echogenic RR 2.61 [1.47; 4.63] within 30 days were observed significantly less plaques on DUS (32) often after CAS than after CEA (0.4% versus 7.1 %; Intraplaque hemorrhage on MRI (33) HR 3.66 [2.70; 4.95] RR 0.09 [0.04; 0.22]). 2 2 Plaque area (< 40 mm vs. > 80 mm ) on HR 5.81 [2.67; 12.67] CTA (9, 34) The timing of revascularization of symptomatic Spontaneous microembolization (TCD) OR 6.63 [2.85; 15.44] carotid stenoses (35) CEA should be performed within 3–14 days after the Spontaneous microembolization PLUS OR 10.6 [2.98; 37.8] neurological index event in order to prevent early re- echo-poor plaques on DUS (36) currence of stroke (↑↑). In a systematic review on the safety of CEA and CAS within the first two weeks, the Limited cerebrovascular reserve capacity OR 6.14 [1.27; 29.5] (TCD) (37) 30-day combined risk of stroke or death was 3.8% for CEA and 6.8% after CAS (18). * Categories of stenosis: 50–69%, 70–89%, 90–99%, 100% ARR, Absolute risk reduction; CCT, cranial computed tomography; CI, confidence interval; CTA, computed The long-term results of carotid stenting and carotid tomography angiography; DUS, duplex sonography; HR, hazard ratio; IRR, incidence rate ratio (relative comparison of incidence); MRI, magnetic resonance tomography; OR, odds ratio; RR, relative risk; TCD, endarterectomy transcranial Doppler sonography; TIA, transient ischemic attack An analysis by the Carotid Stenosis Trialist Collabo- ration (four RCTs on CEA versus CAS in symptomatic stenoses, n = 4775 patients) showed that the combined risk of stroke or death within 120 days was 5.5% for periprocedural stroke rate was 1.3% after CEA versus CEA and 8.7% for CAS. In follow-up periods ranging 2.6% after CAS (OR 0.53, 95% confidence interval from 2 to 7 years, the rates of new ipsilateral stroke [0.29; 0.96]). The reason for this significant differ- were 3.1% and 3.2% for CEA and CAS, respectively. ence was a lower rate of minor strokes after CEA The numbers of events per year, not including peri- (1%) than after CAS (2.2% ) (OR 0.50 [0.25; 1.00]). procedural complications, were almost identical The risks of death, severe stroke, and myocardial in- (CEA 0,6%, CAS 0.64%) (19). farction did not differ significantly. The SPACE-2 study (Stent Protected Angioplasty Routinely collected data from Germany versus Carotid Endarterectomy) is the only three- The quality assurance measures mandated by German arm RCT comparing CEA and CAS with optimized law enable evaluation of the outcome quality of CEA pharmaceutical therapy alone (best medical treat- and CAS under routine conditions. Analysis of all elec- ment, BMT). The trial was halted before completion tive procedures (CEA, 2009–2014: n = 142 074; CAS, because not enough patients could be recruited. 2012–2014: n = 13 086) showed that the combined risk Among the 513 patients analyzed, the 30-day of periprocedural stroke or death was 1.4% for combined rate of stroke and death was 2.5% for asymptomatic and 2.5% for symptomatic carotid both CEA and CAS. At 12 months, almost identical artery stenoses with CEA versus 1.7% and 3.7%, re- results were found for the endpoint “periprocedural spectively, with CAS. The following variables were stroke or death PLUS any ipsilateral ischemic stroke” associated with higher risk: increasing age, physical (CEA 2.5%, CAS 3.0%, BMT 0.9%; p = 0.530). Re- status classification according to the American Socitey current stenosis was somewhat more likely after of Anesthesiology (ASA), symptomatic versus asymp- CAS than after CEA (5.6% versus 2.0%; p = 0.068) tomatic stenosis, 50–69% stenosis, and contralateral (15). carotid artery occlusion (only for CEA) (20). 804 Deutsches Ärzteblatt International | Dtsch Arztebl Int 2020; 117: 801–7
MEDICINE The time that elapsed between neurological index TABLE 4 event and surgery had no influence on the in-hospital periprocedural combined rate of stroke or death for Important recommendations for symptomatic carotid stenosis CEA, but for CAS the risk was elevated in the first 1 Symptomatic carotid stenosis Strength*1 LoE*2 to 2 weeks (21, 22). Modified: CEA should be perfogmed in patients with a 70–99% stenosis after retinal ischemia, TIA, or non-disabling ↑↑ 1a Clinical and morphological variables affecting the stroke. procedural risk Modified: CEA should also be performed in patients with a In the currently valid guideline of the European Society symptomatic 50–69% stenosis when no increased surgical of Cardiology (ESC) and the European Society of An- risk is present. Male patients with a recent history of hemis- ↑ 2a pheric symptoms (retinal ischemia, TIA, cerebral infarction aesthesiology (ESA), CEA is classified as an operation mRS 10 such procedures (↑↑) (26, 27). Moreover, there should be “24-h availability” of diagnostic measures Acceptable rates of periprocedural stroke or (sonography, computer tomography, magnetic resonance death imaging, angiography), monitoring, and endovascular The combined periprocedural rate of stroke or death and surgical intervention (eTable 7). after CEA or CAS for (a)symptomatic stenosis should be as low as possible and should be monitored neuro- Discussion logically. Recent studies and data from the quality as- Almost all of the recommendations contained in this surance register of the German Carotid Registry show revision of the clinical practice guideline on the diag- that most hospitals achieve low complication rates. nosis and treatment of extracranial carotid stenosis After exhaustive discussion, the consensus conference were adopted with strong consensus (≥ 95 %). The up- therefore strongly recommended lowering of the maxi- dated guideline therefore represents a broadly accepted mally acceptable upper limit for complications from basis for the treatment of extracranial carotid stenosis. 3% to 2% for asymptomatic carotid stenoses (NEW, With the publication of numerous RCT, systematic ↑↑). For symptomatic carotid stenoses, the limit was reviews, and meta-analyses, discussion of the role of lowered from 6% to 4% (NEW, EC). CAS has become less controversial and more objec- tive. The literature data show a higher periprocedural Healthcare structures and professional rate of stroke after CAS and higher rates of myocar- qualifications dial ischemia and—predominantly transient—cer- Because around 30% of complications (stroke, myocar- ebral nerve lesions after CEA. The fact that the CAS dial infarction, delayed bleeding) occur later than the complication rate depends on patient age and the day of treatment, CEA and CAS should always be interval between symptom onset and treatment performed as inpatient procedures (EC). Without excep- indicates that advanced atherosclerosis and plaque in- tion, CEA should be carried out by qualified vascular stability are risk factors for CAS. Following interven- surgeons in hospitals with at least 20 such operations tion, there are no significant differences between each year (↑↑) (25–28). CAS should be conducted by CEA and CAS with regard to secondary prevention. Deutsches Ärzteblatt International | Dtsch Arztebl Int 2020; 117: 801–7 805
MEDICINE The primary data on which the analyses are based of extracranial carotid stenosis—a multidisciplinary German-Austrian guideline based on evidence and consensus. Dtsch Arztebl Int 2013; were largely generated no later than 2010. Decreased 110: 468−76. CAS case numbers and complementary indications 3. Eckstein HH KhA, Berkefeld J, Dörfler A, et al.: S3-Leitlinie zur Dia- for CEA hamper comparison of the two methods. gnostik, Therapie und Nachsorge der extracraniellen Carotisstenose, In contrast to the original version of the guideline, Langfassung, Kurzfassung und Leitlinienreport www.awmf.org/leitli nien/detail/ll/004–028.html: AWMF (Arbeitsgemeinschaft der Wissen- this revision defines subgroups of patients in whom schaftlichen Medizinischen Fachgesellschaften) 2020 [last accessed the presence of specific clinical or imaging findings on 23 March 2020]. means that they are at greater risk of carotid artery- 4. de Weerd M, Greving JP, Hedblad B, et al.: Prediction of asymptomatic carotid artery stenosis in the general population: identification of high- associated stroke at a later date. The corresponding risk groups. Stroke 2014; 45: 2366–71. recommendations aim at achieving rational, 5. Hadar N, Raman G, Moorthy D, et al.: Asymptomatic carotid artery evidence-based determination of the indication for stenosis treated with medical therapy alone: temporal trends and im- plications for risk assessment and the design of future studies. revascularization of high-grade asymptomatic ste- Cerebrovasc Dis 2014; 38: 163–73. noses in each individual case. 6. Naylor AR: Time is brain: an update. Expert Rev Cardiovasc Ther Further longitudinal studies of the risk of stroke in 2015; 13: 1111–26. patients with asymptomatic carotid artery stenoses are 7. Arning C, Widder B, von Reutern GM, Stiegler H, Gortler M. [Revision of DEGUM ultrasound criteria for grading internal carotid artery ste- needed to further refine appreciation of the roles of noses and transfer to NASCET measurement]. Ultraschall Med 2010; BMT, clinical variables, and modern methods of 31: 251–7. plaque imaging. 8. Aboyans V, Ricco JB, Bartelink MEL, et al.: 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in In contrast to the original version, the updated collaboration with the European Society for Vascular Surgery (ESVS): clinical practice guideline consented on lowering the Document covering atherosclerotic disease of extracranial carotid acceptable upper limit for the combined rate of stroke and vertebral, mesenteric, renal, upper and lower extremity arteries Endorsed by: the European Stroke Organization (ESO)The Task and death to 2% for asymptomatic stenoses and 4% Force for the Diagnosis and Treatment of Peripheral Arterial Diseases for symptomatic stenoses. While the previously rec- of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J 2018; 39: e35–e41. ommended thresholds of 3% and 6% relate to 30-day 9. Naylor AR, Ricco JB, de Borst GJ, et al.: Editor‘s choice—management results, the revised guideline considers only those of atherosclerotic carotid and vertebral artery disease: 2017 Clinical complications that occur before discharge from hospi- practice guidelines of the european society for vascular surgery (ESVS). Eur J Vasc Endovasc Surg 2018; 55: 3–81. tal. Moreover, registry studies and reviews show that 10. Lanza G, Setacci C, Ricci S, et al.: An update of the Italian Stroke the early outcomes of CEA and CAS have improved Organization-Stroke Prevention Awareness Diffusion Group guidelines in recent years (20). on carotid endarterectomy and stenting: A personalized medicine Furthermore the guideline group has formulated approach. Int J Stroke 2017; 12: 560–7. 11. ISWP: National clinical guideline for stroke, 5th edition, Intercollegiate clear recommendations on healthcare structures and Stroke Working Party. 2016. on the qualifications of the treating physicians. In par- 12. Halliday A, Harrison M, Hayter E, et al.: 10-year stroke prevention ticular, CEA and CAS should be carried out only as after successful carotid endarterectomy for asymptomatic stenosis (ACST-1): a multicentre randomised trial. Lancet 2010; 376: 1074–84. inpatient procedures and only in hospitals with annual 13. Toole JF, Baker WH, Castaldo JE, et al.: Endarterectomy for asymp- caseloads of 20 CEA or 10 CAS. tomatic carotid artery stenosis. J Am Med Assoc 1995; 273: 1421–8. This revision of the clinical practice guideline rec- 14. Cui L, Han Y, Zhang S, Liu X, Zhang J: Safety of stenting and endarte- ommends CEA as standard procedure for high-grade rectomy for asymptomatic carotid artery stenosis: a meta-analysis of randomised controlled trials. Eur J Vasc Endovasc Surg 2018; 55: asymptomatic and for intermediate and high-grade 614–24. symptomatic carotid stenoses. CAS may be consid- 15. Reiff T, Eckstein HH, Mansmann U, et al.: Angioplasty in asympto- ered as an alternative to CEA, provided the center matic carotid artery stenosis vs. endarterectomy compared to best concerned exhibits quality criteria analogous to those medical treatment: One-year interim results of SPACE-2. Int J Stroke 2019: 1747493019833017. for CEA, with maximal complication rates of 2% for 16. Orrapin S, Rerkasem K: Carotid endarterectomy for symptomatic asymptomatic stenoses and 4% for symptomatic ste- carotid stenosis. Cochrane Database Syst Rev 2017; 6: CD001081. noses. The next revision of this guideline is scheduled 17. Ouyang YA, Jiang Y, Yu M, Zhang Y, Huang H: Efficacy and safety of for 2025. stenting for elderly patients with severe and symptomatic carotid ar- tery stenosis: a critical meta-analysis of randomized controlled trials. Clin Interv Aging 2015; 10: 1733–42. Conflict of interest statement The authors declare that no conflict of interest exists. 18. De Rango P, Brown MM, Chaturvedi S, et al.: Summary of evidence on early carotid intervention for recently symptomatic stenosis based Manuscript received on 5 May 2020, revised version accepted on on meta-analysis of current risks. Stroke 2015; 46: 3423–36. 22 June 2020 19. Brott TG, Calvet D, Howard G, et al.: Long-term outcomes of stenting and endarterectomy for symptomatic carotid stenosis: a preplanned Clinical practice guidelines in Deutsches Ärzteblatt International, as in pooled analysis of individual patient data. Lancet Neurol 2019; 18: numerous other specialist journals, are not subject to a peer review 348–56. procedure, since S3 guidelines represent texts that have already been evaluated, discussed, and broadly agreed upon multiple times by experts 20. Eckstein HH, Tsantilas P, Kühnl A, et al.: Surgical and endovascular (peers). treatment of extracranial carotid stenosis—a secondary analysis of statutory quality assurance data from 2009 to 2014. Dtsch Arztebl Int 2017; 114: 729–36. Translated from the original German by David Roseveare 21. Tsantilas P, Kuehnl A, Konig T, et al.: Short time interval between neurologic event and carotid surgery is not associated with an References increased procedural risk. Stroke 2016; 47: 2783–90. 1. Flaherty ML, Kissela B, Khoury JC, et al.: Carotid artery stenosis as a 22. Loftus IM, Paraskevas KI, Johal A, et al.: Editor‘s choice—delays to cause of stroke. Neuroepidemiology 2013; 40: 36–41. surgery and procedural risks following carotid endarterectomy in the 2. Eckstein HH, Kühnl A, Dörfler A, Kopp IB, Lawall H, Ringleb PA: UK National Vascular Registry. Eur J Vasc Endovasc Surg 2016; 52: Clinical Practice Guideline: The diagnosis, treatment and follow-up 438–43. 806 Deutsches Ärzteblatt International | Dtsch Arztebl Int 2020; 117: 801–7
MEDICINE 23. Kristensen SD, Knuuti J, Saraste A, et al.: 2014 ESC/ESA Guidelines on 33. Gupta A, Baradaran H, Schweitzer AD, et al.: Carotid plaque MRI and stroke risk: non-cardiac surgery: cardiovascular assessment and management: The Joint a systematic review and meta-analysis. Stroke 2013; 44: 3071–7. Task Force on non-cardiac surgery: cardiovascular assessment and management 34. Nicolaides AN, Kakkos SK, Kyriacou E, et al.: Asymptomatic internal carotid artery of the European Society of Cardiology (ESC) and the European Society of stenosis and cerebrovascular risk stratification. J Vasc Surg 2010; 52: 1486–96 Anaesthesiology (ESA). Eur J Anaesthesiol 2014; 31: 517–73. e1–5. 24. Knappich C, Kuehnl A, Haller B, et al.: Associations of perioperative variables with the 30-day risk of stroke or death in carotid endarterectomy for symptomatic carotid 35. Markus HS, King A, Shipley M, Topakian R, et al.: Asymptomatic embolisation stenosis. Stroke 2019; 50: 3439–48. for prediction of stroke in the Asymptomatic Carotid Emboli Study (ACES): a prospective observational study. Lancet Neurol 2010; 9: 663–71. 25. Hussain MA, Mamdani M, Tu JV, et al.: Association between operator specialty and outcomes after carotid artery revascularization. J Vasc Surg 2018; 67: 478–89 e6. 36. Topakian R, King A, Kwon SU, et al.: Ultrasonic plaque echolucency and emboli doi: 10.1016/j.jvs.2017.05.123. signals predict stroke in asymptomatic carotid stenosis. Neurology 2011; 77: 26. Poorthuis MHF, Brand EC, Halliday A, Bulbulia R, Bots ML, de Borst GJ: Response 751–8. to Comment on “High operator and hospital volume are associated with a decreased 37. King A, Serena J, Bornstein NM, Markus HS: Does impaired cerebrovascular risk of death and stroke following carotid revascularization: a systematic review and reactivity predict stroke risk in asymptomatic carotid stenosis?: A prospective sub- meta-analysis: Authors‘ Reply“. Ann Surg 2019; 270: e50–1. study of the asymptomatic carotid emboli study. Stroke 2011; 42: 1550–5. 27. Poorthuis MHF, Brand EC, Halliday A, et al.: High operator and hospital volume are associated with a decreased risk of death and stroke after carotid revascularization: Corresponding author a systematic review and meta-analysis. Ann Surg 2019; 269: 631–41. Prof. Dr. med. Hans-Henning Eckstein 28. Kuehnl A, Tsantilas P, Knappich C, et al.: Significant association of annual hospital Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie volume with the risk of inhospital stroke or death following carotid endarterectomy Klinikum rechts der Isar der Technischen Universität München but likely not after carotid stenting: secondary data analysis of the statutory german Ismaninger Str. 22, 81675 München, Germany carotid quality assurance database. Circ Cardiovasc Interv 2016; 9: e004171. HHEckstein@web.de 29. Kakkos SK, Nicolaides AN, Charalambous I, et al.: Predictors and clinical significance of progression or regression of asymptomatic carotid stenosis. J Vasc Cite this as: Surg 2014; 59: 956–67 e1. Eckstein HH, Kühnl A, Berkefeld J, Lawall H, Storck M, Sander D: 30. Kakkos SK, Sabetai M, Tegos T, et al.: Silent embolic infarcts on computed Clinical practice guideline: Diagnosis, treatment and follow-up in extracranial carotid tomography brain scans and risk of ipsilateral hemispheric events in patients with stenosis. Dtsch Arztebl Int 2020; 117: 801–7. DOI: 10.3238/arztebl.2020.0801 asymptomatic internal carotid artery stenosis. J Vasc Surg 2009; 49: 902–9. ►Supplementary material 31. Hirt LS: Progression rate and ipsilateral neurological events in asymptomatic carotid stenosis. Stroke 2014; 45: 702–6. For eReferences please refer to: www.aerzteblatt-international.de/ref4720 32. Gupta A, Kesavabhotla K, Baradaran H, et al.: Plaque echolucency and stroke risk in asymptomatic carotid stenosis: a systematic review and meta-analysis. Stroke eMethods, eTables: 2015; 46: 91–7. www.aerzteblatt-international.de/20m0801 Deutsches Ärzteblatt International | Dtsch Arztebl Int 2020; 117: 801–7 807
MEDICINE Supplementary material to: Diagnosis, Treatment and Follow-up in Extracranial Carotid Stenosis by Hans-Henning Eckstein, Andreas Kühnl, Joachim Berkefeld, Holger Lawall, Martin Storck, and Dirk Sander Dtsch Arztebl Int 2020; 117: 801–7. DOI: 10.3238/arztebl.2020.0801 eReferences e1. Kernan WN, Ovbiagele B, Black HR, et al.: Guidelines for the e8. DGN und DSG: Schlaganfall: Sekundärprophylaxe ischämischer prevention of stroke in patients with stroke and transient ischemic Schlaganfall und transitorische ischämische Attacke 2015. Available attack: a guideline for healthcare professionals from the American from: awmf.org (last accessed on 5 April 2019). Heart Association/American Stroke Association. Stroke 2014; 45: 2160–236. e9. Catapano AL, Graham I, De Backer G, et al.: [2016 ESC/EAS Guidelines for the Management of Dyslipidaemias]. Kardiol Pol e2. Meschia JF, Bushnell C, Boden-Albala B, et al.: Guidelines 2016; 74: 1234–318. for the primary prevention of stroke: a statement for healthcare professionals from the American Heart Association/American Stroke e10. Intercollegiate Stroke Working Party. National clinical guideline for Association. Stroke 2014; 45: 3754–832. stroke, 5th edition. London: Royal College of Physicians. 2016. e3. Bushnell C, McCullough LD, Awad IA, et al.: Guidelines for the pre- e11. Foundation AS: Clinical Guidelines for Stroke Management 2017. vention of stroke in women: a statement for healthcare professionals www.informme.org.au/en/Guidelines/Clinical-Guidelines-for-Stroke- from the American Heart Association/American Stroke Association. Management-2017 (last accessed on 6 February 2020). Stroke 2014; 45: 1545–88. e4. Coutts SB, Wein TH, Lindsay MP, et al.: Canadian stroke best prac- e12. Powers WJ, Rabinstein AA, Ackerson T, et al.: 2018 Guidelines for tice recommendations: secondary prevention of stroke guidelines, the early management of patients with acute ischemic stroke: update 2014. Int J Stroke 2015; 10: 282–91. a guideline for healthcare professionals from the American Heart e5. Redmon B, Caccamo D, Flavin P, et al.: Diagnosis and management Association/American Stroke Association. Stroke 2018; 49: e46-e110. of type 2 diabetes mellitus in adults. Institute for Clinical Systems e13. Zierler RE, Jordan WD, Lal BK, et al.: The society for vascular sur- Improvement. Updated July 2014. gery practice guidelines on follow-up after vascular surgery arterial e6. Longrois D, Hoeft A, De Hert S: 2014 European Society of procedures. J Vasc Surg 2018; 68: 256–84. Cardiology/European Society of Anaesthesiology guidelines on non- cardiac surgery: cardiovascular assessment and management: A e14. Williams B, Mancia G, Spiering W, et al.: 2018 ESC/ESH Guidelines short explanatory statement from the European Society of Anaes- for the management of arterial hypertension. Eur Heart J 2018; 39: thesiology members who participated in the European Task Force. 3021–104. Eur J Anaesthesiol 2014; 31: 513–6. e15. Turc G, Bhogal P, Fischer U, et al.: European Stroke Organisation e7. Ringleb P, Veltkamp R: Leitlinien für Diagnostik und Therapie (ESO)—European Society for Minimally Invasive Neurological Ther- in der Neurologie: Akuttherapie des ischämische Schlaganfalls – apy (ESMINT) guidelines on mechanical thrombectomy in acute Ergänzung 2015: Rekanalisierende Therapie. DGN 2016: 1–26. ischemic stroke. J Neurointerv Surg 2019; neurintsurg-2018–014569. I Deutsches Ärzteblatt International | Dtsch Arztebl Int 2020; 117: 801–7 | Supplementary material
MEDICINE eFIGURE Systematic literature search in databases (Medline, Embase, SciSearch, NHS Economic, Elsevier Biobase) (Publishers’ databases:Thieme, Springer, Kluwer, Karger, LWW, DAEB, GMS) Systematic literature search in databases caroti (stenosis, stenotic, obstruct, arteriosclero, dissect, stent, angioplast, thrombarterect, thrombendarterec) Literature search 1st edition up to 6. 12. 2011 > 20 000 articles Search terms: Group-specific literature search See guideline report of clinical practice guideline: Diagnosis, Treatment and Follow-up for Extracranial Carotid Stenosis Group-specific literature search Epidemiology Diagnosis Treatment Follow-up and reha- Other 433 articles 924 articles 2316 articles bilitation 807 articles 33 MA/SR 52 MA/SR 122 MA/SR 74 articles 93 MA/SR 8 RCT 23 RCT 108 RCT 8 MA/SR 43 RCT Search terms: 5 RCT Including: national and international guidelines on – Invasive treatment (carotid endarterectomy, carotid stent) 11 – Primary and secondary prevention of cerebral ischemia 32 Update of systematic literature search Literature search 2nd edition from 1. 1. 2011 (see guideline report 9.1) Search for guidelines Search for SR and MA in in GIN, TRIP, SIGN, Medline, Embase, Embase Alert, Cochrane NICE, KCE, Database of Systematic Reviews, Prospero, IQWIG, NGC Epistemonikos, TRIP 645 articles 4921 articles Including, from 2014 Including, from 2011 18 guidelines 75 SR/MA (see eTable 3) (see guideline report 9.3.2) Flow chart of literature search DAEB, Database of Deutsches Ärzteblatt; GIN, Guidelines International Network; GMS, German Medical Science Database; IQWIG, Institute for Quality and Efficiency in Health Care; KCE, Belgian Health Care Knowledge Centre; LWW, database of Lippincott Williams & Wilkins; MA, systematic review with meta-analysis; NGC, National Guideline Clearinghouse; NHS Economic, National Health Service Economic Evaluation Database; NICE, National Institute for Health and Care Excellence; RCT, randomized ccontrolled trial; SIGN, Scottish Intercollegiate Guidelines Network; SR, systematic review; TRIP, Turning Research Into Practice Deutsches Ärzteblatt International | Dtsch Arztebl Int 2020; 117: 801–7 | Supplementary material II
MEDICINE eTABLE 1 Participating professional societies and interest groups Society/organization Officer 2019 (revised guideline) German Vascular Society Prof. H.-H. Eckstein, Munich German Society of Neurology Prof. P. Ringleb, Heidelberg Prof. D. Sander, Tutzing German Society for Neurorehabilitation No delegate nominated, active decision not to participate German Stroke Society Prof. P. Ringleb, Heidelberg Prof. Dr. D.G. Nabavi, Berlin German Society for Ultrasound in Medicine Prof. M. Köhrmann, Essen Prof. P. Ringleb, Heidelberg German Society for Neuroradiology Prof. J. Berkefeld, Frankfurt Prof. A. Dörfler, Erlangen German Radiological Society Prof. W. Gross-Fengels, Harburg German Society of Interventional Radiology and Prof. P. Huppert, Darmstadt Minimally Invasive Therapy German Society of Angiology/Vascular Medicine Dr. H. Lawall, Langensteinbach Dr. R. Langhoff, Berlin German Cardiac Society Prof. H. Mudra, Munich Prof. T. Zeller, Bad Krozingen German Diabetes Society Prof. O. Schnell, Munich PD Dr. K. Rittig, Frankfurt (Oder) German Society of Gerontology and Geriatrics Dr. C. Ploenes, Düsseldorf Dr. H. Görtz, Lingen Austrian Union of Vascular Medicine Prof. G. Fraedrich, Innsbruck Prof. B. Rantner, Munich German Society for Thoracic and Cardiovascular Surgery Prof. M. Czerny, Freiburg German Society of Neurosurgery Prof. K. Schwerdtfeger, Homburg German Society of Surgery Prof. M. Storck, Karlsruhe Prof. M. Steinbauer, Regensburg German Society of Anaesthesiology and Intensive Care Medicine Dr. R. Litz, Augsburg Prof. K. Engelhard, Mainz German College of General Practitioners and Family Physicians No delegate nominated, active decision not to participate German Society for the Prevention and Rehabilitation of No delegate nominated, no reply to invitation Cardiovascular Disease Association of the Scientific Medical Societies in Germany Prof. I. Kopp, Marburg German Vascular League Dr. S. Schulte, Cologne German Association for Physiotherapy A. Fründ, Bad Oeynhausen German Association of Occupational Therapists A. Hörstgen, Karslbad C. Lüdeking, Minden German Nurses Association R. Schamberger, Regensburg J. Hanl, Friedrichshafen German Patient Support Group No delegate nominated, no reply to invitation Bavarian Association of Stroke Victims Munich No delegate nominated, no reply to invitation German Stroke Relief Group Prof. Dr. D.G. Nabavi, Berlin Prof. Dr. R. Stingele, Berlin III Deutsches Ärzteblatt International | Dtsch Arztebl Int 2020; 117: 801–7 | Supplementary material
MEDICINE eTABLE 2 National and international guidelines relevant to the management of extra- cranial carotid stenoses, 2014–2019 Year Scientific societies Topic of guideline 2014 American Heart Association/ Prevention of stroke in patients with American Stroke Association stroke and transient ischemic attack (e1) 2014 American Heart Association/ Primary prevention of stroke (e2) American Stroke Association 2014 American Heart Association/ Prevention of stroke in women (e3) American Stroke Association 2014 Canada Best practice for stroke care (e4) 2014 Institute for Clinical Systems Diagnosis and management of type Improvement 2 diabetes mellitus in adults (e5) 2014 European Society of Cardiology Non-cardiac surgery: cardiovascular (ESC) and European Society of An- assessment and management (e6) aesthesiology 2015 German Society of Neurology Acute treatment of ischemic stroke (supplement) – recanalization treatment (e7) 2015 German Society of Neurology and Secondary prophylaxis of ischemic German Stroke Society stroke and transient ischemic attack, part 1 (e8) 2016 ESC and European Management of dyslipidemias (e9) Atherosclerosis Society 2016 Royal College of Physicians Stroke (e10) 2018 European Society for Vascular Management of carotid artery dis- Surgery (ESVS) in collaboration with ease ESC 2018 ESC in collaboration with ESVS Diagnosis and treatment of periph- eral arterial diseases 2017 Italian Stroke Organization CEA and CAS (14) 2017 The Stroke Foundation, Australia Clinical stroke management (e11) 2018 American Heart Association/ Early management of patients with American Stroke Association acute ischemic stroke (e12) 2018 Society for Vascular Surgery Follow-up after vascular surgery (e13) 2018 ESC and European Society for Management of arterial hypertension Hypertension (e14) 2019 European Stroke Organization and Mechanical thrombectomy in acute European Society for ischemic stroke (e15) Minimally Invasive Neurological Therapy Deutsches Ärzteblatt International | Dtsch Arztebl Int 2020; 117: 801–7 | Supplementary material IV
MEDICINE eTABLE 3 Classification of level of evidence (LoE) and recommendation strength Study quality LoE Recommendation Description Symbol Systematic review (meta-analysis) or high-quality randomized controlled Strongly 1 (high) Should ↑↑ trials (RCT) or cohort studies recommended RCT or cohort studies of limited quality 2–3 (moderate) Should be considered Recommended ↑ RCT or cohort studies of poor quality, all other study designs Open recommen- 4–5 (weak) May be considered ↔ dation Expert opinion None Expert consensus – EC V Deutsches Ärzteblatt International | Dtsch Arztebl Int 2020; 117: 801–7 | Supplementary material
MEDICINE eTABLE 4 Important recommendations for the diagnosis of carotid stenoses Definition of asymptomatic and symptomatic carotid stenosis Strength*1 LoE*2 Unchanged: A stenosis is classified as asymptomatic when no stenosis-associated symptoms have occurred during the previous EC 6 months. Modified: When a carotid stenosis has caused an ipsilateral cerebral infarction, ipsilateral transient ischemic attack, or ipsilateral reti- EC nal ischemia during the previous 6 months, it is classified as symptomatic. Diagnosis and follow-up of extracranial carotid stenosis Strength*1 LoE*2 Modified: Whenever carotid stenosis is suspected, color-coded DUS should be performed by an experienced examiner. ↑↑ 1 Unchanged: If there is any doubt about grading of the carotid stenosis, or if DUS is complicated by additive intrathoracic or intracran- EC ial vascular processes or by hemodynamically relevant contralateral vascular alterations, additional CTA or MRA is recommended. What diagnostic measures are necessary before the planned operation or intervention? Strength*1 LoE*2 Unchanged: All patients with carotid stenoses should undergo clinical neurological examination. EC New: If CEA is considered, every DUS should be confirmed by means of CTA or MRA, or by repeated DUS performed by another ↑ 1 qualified examiner. New: If CAS is considered, every DUS should be supplemented by CTA or MRA to obtain additional information about the aortic arch, ↑↑ 1 the stenosis morphology, and the extracranial and intracranial circulation. Unchanged: Planned revascularization of the carotid artery should be preceded, in symptomatic patients, by imaging of the brain EC parenchyma. Such imaging can also yield important additional information in asymptomatic patients. Is screening (of high-risk groups) useful? Strength*1 LoE*2 Unchanged: Routine screening for carotid stenosis should not be performed. ↓↓ 1 Modified: In the presence of vascular risk factors and/or existing atherosclerotic disease in other territories, DUS of the carotid artery EC may be helpful. This examination should be limited to patients in whom therapeutic consequences can be anticipated. New: The sonographic detection of atherosclerotic carotid plaques may affect the cardiovascular risk estimation. EC *1 Recommendation strength: ↑↑/↓↓, strongly recommended/definitely not recommended; ↑/↓, recommended/not recommended ↔, open recommendation *2 Level of evidence (LoE) 1–5 according to the Oxford Centre for Evidence-Based Medicine 2009 (see guideline report for this clinical practice guideline) CAS, Carotid stenting; CEA, carotid endarterectomy; CTA, computed tomographic angiography; DUS, duplex sonography; EC, expert consensus; MRA, magnetic resonance tomography Deutsches Ärzteblatt International | Dtsch Arztebl Int 2020; 117: 801–7 | Supplementary material VI
MEDICINE eTABLE 5 Important recommendations for follow-up examinations after CEA or CAS Strength*1 LoE*2 New: If early DUS follow-up shows a good result, DUS should be repeated after 6 months to rule out early recurrence of stenosis. EC New: DUS should be performed routinely at 12-month intervals after CEA and CAS, provided the findings could have therapeutic con- EC sequences. New: In patients thought to be at an elevated risk of recurrent stenosis during follow-up (women, diabetes mellitus, dyslipidemia, nic- otine abuse) DUS should be repeated at 6-month intervals after CEA and after CAS. As soon as two successive examinations show EC the same findings, the interval can be increased to 12 months. *1 Recommendation strength: ↑↑/↓↓, strongly recommended/definitely not recommended; ↑/↓, recommended/not recommended ↔, open recommendation *2 Level of evidence (LoE) 1–5 according to the Oxford Centre for Evidence-Based Medicine 2009 (see guideline report for this clinical practice guideline) CAS, Carotid stenting; CEA, carotid endarterectomy; DUS, duplex sonography; EC, expert consensus VII Deutsches Ärzteblatt International | Dtsch Arztebl Int 2020; 117: 801–7 | Supplementary material
MEDICINE eTABLE 6 Important recommendations for assessment of the periprocedural treatment risk with CEA and CAS Recommendations for CEA Strength*1 LoE*2 New: When determining whether CEA is indicated, and to estimate the preventive value of surgery, it should be considered that the following comorbidities may negatively influence the treatment-associated risk and the prognosis of CEA: – Coronary heart disease (CHD) – Heart failure (ejection fraction < 30%, pathologic stress test) – Arterial hypertension (especially elevated diastolic blood pressure) ↑↑ 2a – Diabetes mellitus (especially if treated with insulin) – Respiratory failure (especially COPD) – Severe kidney failure – Known peripheral arterial occlusive disease – Nicotine abuse (current or past) Modified: When determining whether CEA is indicated and explaining the procedure to the patient, one should take into account that the perioperative risk of stroke and death is higher for symptomatic than for ↑↑ 2a asymptomatic carotid stenoses. Unchanged: When determining whether CEA is indicated, one should take into account that the perioperative risk of stroke and death is not higher for early elective CEA (within 2 weeks after the index event) than after ↑↑ 2a delayed CEA (> 2 weeks). Unchanged: When determining whether CEA is indicated, one should take into account that perioperative ↑↑ 2a mortality in both men and women increases with advancing age, but the perioperative stroke rate does not. New: In the presence of clinical signs of CHD, elective CEA should be preceded by a guideline-conform staged diagnostic work-up, including non-invasive and invasive techniques, to minimize the perioperative and ↑↑ 2a long-term risk of myocardial infarction. New: In the absence of clinical signs of CHD, non-invasive tests may be considered to minimize the peri- ↔ 2b operative and long-term risk of myocardial infarction. New: When evaluating the risks and benefits of CEA, functional parameters (activities of daily living, func- ↑ 2a tional autonomy, progressive deterioration of general health) should be considered. New: When determining whether CEA is indicated, one should take into account that the following anatomic morphological variables are associated with higher procedural risk: – Tracheostomy – Contralateral paresis of the recurrent laryngeal nerve ↑ 2b – High carotid bifurcation (C2 or above) – Contralateral carotid occlusion – Moderate (50 to 69%) stenoses (versus 70 to 99% stenoses) – Insufficient intracranial collateral blood supply Recommendations for CAS Strength*1 LoE*2 Unchanged: When determining whether CAS is indicated, one should consider whether the patient’s age and comorbidities may increase the risk of extracerebral complications or limit the prophylactic benefit of the inter- EC vention. New: When determining whether CAS is indicated and explaining the procedure to the patient, one should take into account that the peri-interventional risk of stroke and death is higher for symptomatic than for ↑↑ 2 asymptomatic carotid stenoses. New: Before deciding to perform CAS, one should carefully weigh up the benefits and risks. The risks may be greater in patients over 70 years of age and after recent cerebral or ocular ischemia. It may be advisable to ↑ 2a consider CEA as an alternative. New: When determining whether CAS is indicated, anatomic and plaque morphology factors should be taken into account. Particularly the following variables are associated with higher procedural risk: – Pronounced aortic elongation (especially type III aortic arch) – Stenosis of the left carotid artery – Angulation of the carotid bifurcation ↑ 2b – Calcification of the aortic arch – Pronounced (especially circumferential) plaque calcification – Long-segment stenosis ( > 10 mm) – Free-floating thrombus *1 Recommendation strength: ↑↑/↓↓, strongly recommended/definitely not recommended; ↑/↓, recommended/not recommended ↔, open recommendation *2 Level of evidence (LoE) 1–5 according to the Oxford Centre for Evidence-Based Medicine 2009 (see guideline report for this clinical practice guideline) CAS, Carotid stenting; CEA, carotid endarterectomy; CHD, coronary heart disease; COPD, chronic occlusive pulmonary disease; EC, expert consensus Deutsches Ärzteblatt International | Dtsch Arztebl Int 2020; 117: 801–7 | Supplementary material VIII
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